An economic analysis of immediate delivery and expectant monitoring in women with hypertensive disorders of pregnancy, between 34 and 37 weeks of gestation (HYPITAT-II).

OBJECTIVE: To assess the economic consequences of immediate delivery compared with expectant monitoring in women with preterm non-severe hypertensive disorders of pregnancy. DESIGN: A cost-effectiveness analysis alongside a randomised controlled trial (HYPITAT-II). SETTING: Obstetric departments of seven academic hospitals and 44 non-academic hospitals in the Netherlands. POPULATION: Women diagnosed with non-severe hypertensive disorders of pregnancy between 340/7 and 370/7  weeks of gestation, randomly allocated to either immediate delivery or expectant monitoring. METHODS: A trial-based cost-effectiveness analysis was performed from a healthcare perspective until final maternal and neonatal discharge. MAIN OUTCOME MEASURES: Health outcomes were expressed as the prevalence of respiratory distress syndrome, defined as the need for supplemental oxygen for >24 hours combined with radiographic findings typical for respiratory distress syndrome. Costs were estimated from a healthcare perspective until maternal and neonatal discharge. RESULTS: The average costs of immediate delivery (n = 352) were €10 245 versus €9563 for expectant monitoring (n = 351), with an average difference of €682 (95% confidence interval, 95% CI -€618 to €2126). This 7% difference predominantly originated from the neonatal admissions, which were €5672 in the immediate delivery arm and €3929 in the expectant monitoring arm. CONCLUSION: In women with mild hypertensive disorders between 340/7 and 370/7  weeks of gestation, immediate delivery is more costly than expectant monitoring as a result of differences in neonatal admissions. These findings support expectant monitoring, as the clinical outcomes of the trial demonstrated that expectant monitoring reduced respiratory distress syndrome for a slightly increased risk of maternal complications. TWEETABLE ABSTRACT: Expectant management in preterm hypertensive disorders is less costly compared with immediate delivery.

Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial.

OBJECTIVE: To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage. DESIGN: Randomised non-inferiority trial. SETTING: Thirty-seven Dutch university and general hospitals. POPULATION: Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities. METHODS: Women were allocated to RBC transfusion or non-intervention. MAIN OUTCOME MEASURES: Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum. RESULTS: In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable. CONCLUSIONS: Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified.

Economic analysis of use of pessary to prevent preterm birth in women with multiple pregnancy (ProTWIN trial).

OBJECTIVE: To assess the cost-effectiveness of a cervical pessary to prevent preterm delivery in women with a multiple pregnancy. METHODS: The study design comprised an economic analysis of data from a randomized clinical trial evaluating cervical pessaries (ProTWIN). Women with a multiple pregnancy were included and an economic evaluation was performed from a societal perspective. Costs were estimated between the time of randomization and 6 weeks postpartum. The prespecified subgroup of women with a cervical length (CL) < 25(th) centile (< 38 mm) was analyzed separately. The primary endpoint was poor perinatal outcome occurring up to 6 weeks postpartum. Direct medical costs and health outcomes were estimated and incremental cost-effectiveness ratios for costs to prevent one poor outcome were calculated. RESULTS: Mean costs in the pessary group (n = 401) were € 21,783 vs € 21,877 in the group in which no pessary was used (n = 407) (difference, -€ 94; 95% CI, -€ 5975 to € 5609). In the prespecified subgroup of women with a CL < 38 mm we demonstrated a significant reduction in poor perinatal outcome (12% vs 29%; RR, 0.40; 95% CI, 0.19-0.83). Mean costs in the pessary group (n = 78) were € 25,141 vs € 30,577 in the no-pessary group (n = 55) (difference, -€ 5436 (95% CI, -€ 11,001 to € 1456). In women with a CL < 38 mm, pessary treatment was the dominant strategy (more effective and less costly) with a probability of 94%. CONCLUSION: Cervical pessaries in women with a multiple pregnancy involve costs comparable to those in women without pessary treatment. However, in women with a CL < 38 mm, treatment with a cervical pessary appears to be highly cost-effective.

Keeping medical science trustworthy: The threat by predatory journals.

Since most scientific journals tend to ask article processes costs from authors, a new category of journals has developed of which the business model is commonly exclusively based on financial contributions by authors. Such journals have become known as predatory journals. The financial contributions that they ask are not always lower than those asked by high-quality journals although they offer less: there is commonly no real review, texts are not edited, and there are commonly no printed editions. The lack of serious reviews makes predatory journals attractive, however, particularly for authors of low-quality (or even fraudulent) manuscripts. It is shown here that numerous - commonly fairly recent - journals, some of which may predatory, attract manuscripts by approaching authors of articles in high-quality journals like Complementary Therapies in Medicine. Publication of articles in such journals contaminates thorough literature and undermines the trustworthiness of the medical society. Any involvement in such journals (as an author, reviewer or editor) of such journals should therefore be discouraged.

Rest is essential for effective therapies, and so it is for preparing a manuscript.

Numerous medical articles are commented upon. This suggests that their scientific quality is insufficient. This need not be the case, however: most comments regard the presentation of the data, the conclusions or lacking information in the discussion. Such flaws can commonly be attributed to either too much haste in writing the manuscript, or insufficient time between finishing the manuscript and submission; this last problem seems the most common cause, as it deprives the author from reading his own text critically and with an open mind. The solution for this problem is simple: after having finished a manuscript, it should be laid aside for at least a week, after which the author should read it with the eyes of a reader, not the eyes of an author. Critical, open-minded reading after rest helps increase the quality of the resulting manuscript, just like rest helps a patient during most therapies.

Changing roles of the corresponding author - Consequences for the accessibility of medical information.

It appears that ever more frequently the corresponding author of a multi-author manuscript is not what he/she was originally supposed to be: the most involved researcher with the best overview concerning the presented study. Numerous journals now use the term 'corresponding author', however, for the author who acts as a kind of secretary for the submitted manuscript, irrespective of his/her expertize in the subject. Another problem is that a significant number of universities give more scientific credits to the corresponding author than to his/her co-authors, which fairly commonly results in granting the corresponding authorship to the student or young scientist who needs scientific credits most urgently for his/her academic career. Consequently, readers of a multi-author article are nowadays hardly able to judge which author of an interesting article might best be contacted for additional information. An increasing number of journals seem unaware of the problems that this changing role of the corresponding author may cause. The present contribution both mentions the main resulting problems and proposes possible solutions.

Should cervical favourability play a role in the decision for labour induction in gestational hypertension or mild pre-eclampsia at term? An exploratory analysis of the HYPITAT trial.

OBJECTIVE: To examine whether cervical favourability (measured by cervical length and the Bishop score) should inform obstetricians' decision regarding labour induction for women with gestational hypertension or mild pre-eclampsia at term. DESIGN: A post hoc analysis of the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT). SETTING: Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands. POPULATION: A total of 756 women diagnosed with gestational hypertension or pre-eclampsia between 36 + 0 and 41 + 0 weeks of gestation randomly allocated to induction of labour or expectant management. METHODS: Data were analysed using logistic regression modelling. MAIN OUTCOME MEASURES: The occurrence of a high-risk maternal situation defined as either maternal complications or progression to severe disease. Secondary outcomes were caesarean delivery and adverse neonatal outcomes. RESULTS: The superiority of labour induction in preventing high-risk situations in women with gestational hypertension or mild pre-eclampsia at term varied significantly according to cervical favourability. In women who were managed expectantly, the longer the cervix the higher the risk of developing maternal high-risk situations, whereas in women in whom labour was induced, cervical length was not associated with a higher probability of maternal high-risk situations (test of interaction P = 0.03). Similarly, the beneficial effect of labour induction on reducing the caesarean section rate was stronger in women with an unfavourable cervix. CONCLUSION: Against widely held opinion, our exploratory analysis showed that women with gestational hypertension or mild pre-eclampsia at term who have an unfavourable cervix benefited more from labour induction than other women. TRIAL REGISTRATION: The trial has been registered in the clinical trial register as ISRCTN08132825.

Hardly traceable pitfalls in medical review articles.

The main purpose of review articles is to increase insight into the best possible practice for increasing the health condition of future subjects. This requires the collection of as many relevant data as possible from earlier case studies, but such data should be mutually independent. If the data from the reviewed single- or multi-case studies are not entirely mutually independent, the conclusions of the review study may easily - though not necessarily - become biased. This is shown on the basis of a 2020 systematic review about the effects of deep dry needling on spasticity and related physical disabilities. We analyzed this study by checking undisclosed possible overlaps regarding the subjects dealt with in the various case studies that were reviewed. This analysis raised also some questions about the accuracy of the number of subjects that had been treated, which is an aspects of which errors can commonly not be disclosed by the readers. The objective of our Letter is to show that insufficient attention by authors, editor and reviewers for an unambiguous presentation of the data regarding the subjects dealt with can make it impossible for readers to draw correct conclusions regarding the optimization of possible treatments.

An economic analysis of induction of labour and expectant monitoring in women with gestational hypertension or pre-eclampsia at term (HYPITAT trial).

OBJECTIVE: To assess the economic consequences of labour induction compared with expectant monitoring in women with gestational hypertension or pre-eclampsia at term. DESIGN: An economic analysis alongside the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT). SETTING: Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands. POPULATION: Women diagnosed with gestational hypertension or pre-eclampsia between 36(+0) and 41(+0) weeks of gestation, randomly allocated to either induction of labour or expectant monitoring. METHODS: A trial-based cost-effectiveness analysis was performed from a societal perspective during a 1-year time horizon. MAIN OUTCOME MEASURES: One-year costs were estimated and health outcomes were expressed as the prevalence of poor maternal outcome defined as either maternal complications or progression to severe disease. RESULTS: The average costs of induction of labour (n = 377) were €7077 versus €7908 for expectant monitoring (n = 379), with an average difference of -€831 (95% CI -€1561 to -€144). This 11% difference predominantly originated from the antepartum period: per woman costs were €1259 for induction versus €2700 for expectant monitoring. During delivery, more costs were generated following induction (€2190) compared with expectant monitoring (€1210). No substantial differences were found in the postpartum, follow-up and for non-medical costs. CONCLUSION: In women with gestational hypertension or mild pre-eclampsia at term, induction of labour is less costly than expectant monitoring because of differences in resource use in the antepartum period. As the trial already demonstrated that induction of labour results in less progression to severe disease without resulting in a higher caesarean section rate, both clinical and economic consequences are in favour of induction of labour in these women. TRIAL REGISTRATION: The trial has been registered in the clinical trial register as ISRCTN08132825.

[Struma ovarii during pregnancy]. / Struma ovarii tijdens de zwangerschap.

A 41-year-old pregnant woman, gravida 10, para 7, with gestational diabetes, was diagnosed with subclinical hyperthyroidism. At 16-weeks gestation a left-sided unilateral ovarian cyst was discovered. At 37 weeks of pregnancy an elective caesarean section was carried out, due to the transverse presentation caused by the cyst, followed by an adnexectomy. Histological examination showed a struma ovarii, a rare mature ovarian teratoma mainly consisting of thyroid tissue. There was no evidence of malignancy.

Risk stratification for healthcare planning in women with gestational diabetes mellitus.

BACKGROUND: To identify relevant factors predicting the need for insulin therapy in women with gestational diabetes mellitus (GDM) and secondly to determine a potential 'low- risk' diet-treated group who are likely to have good pregnancy outcomes. METHODS: A retrospective analysis between 2011-2014. Multivariable backward stepwise logistic regression was used to identify the predictors of the need for insulin therapy. To identify a 'low-risk' diet-treated group, the group was stratified according to pregnancy complications. Diet-treated women with indications for induction in secondary care were excluded. RESULTS: A total of 820 GDM women were included, 360 (44%) women required additional insulin therapy. The factors predicting the need for insulin therapy were: previous GDM, family history of diabetes, a previous infant weighing ≥ 4500 gram, Middle-East/North-African descent, multiparity, pre-gestational BMI ≥ 30 kg/m2, and an increased fasting glucose level ≥ 5.5 mmol/l (OR 6.03;CI 3.56-10.22) and two-hour glucose level ≥ 9.4 mmol/l after a 75-gram oral glucose tolerance test at GDM diagnosis. In total 125 (54%) women treated with diet only had pregnancy complications. Primiparity and higher weight gain during pregnancy were the best predictors for complications (predictive probability 0.586 and 0.603). CONCLUSION: In this GDM population we found various relevant factors predicting the need for insulin therapy. A fasting glucose level ≥ 5.5 mmol/l at GDM diagnosis was by far the strongest predictor. Women with GDM who had good glycaemic control on diet only with a higher parity and less weight gain had a lower risk for pregnancy complications.

Prediction of neonatal outcome in women with gestational hypertension or mild preeclampsia after 36 weeks of gestation.

BACKGROUND: There is little knowledge about neonatal complications in GH and PE and induction at term, we aim to assess whether they can be predicted from clinical data. METHODS: We used data of the HYPITAT trial and evaluated whether adverse neonatal outcome (Apgar score < 7, pH < 7.05, NICU admission) could be predicted from clinical data. Logistic regression, ROC analysis and calibration were used to identify predictors and evaluate the predictive capacity in an antepartum and intrapartum model. RESULTS: We included 1153 pregnancies, of whom 76 (6.6%) had adverse neonatal outcome. Parity (primipara OR 2.75), BMI (OR 1.06), proteinuria (dipstick +++ OR 2.5), uric acid (OR 1.4) and creatinine (OR 1.02) were independent antepartum predictors; In the intrapartum model, meconium stained amniotic fluid (OR 2.2), temperature (OR 1.8), duration of first stage of labour (OR 1.15), proteinuria (dipstick +++ OR 2.7), creatinine (OR 1.02) and uric acid (OR 1.5) were predictors of adverse neonatal outcome. Both models showed good discrimination (AUC 0.75 and 0.78), but calibration was limited (Hosmer-Lemeshow p = 0.41, and p = 0.20). CONCLUSIONS: In women with GH or PE at term, it is difficult to predict neonatal complications, possibly since they are rare in the term pregnancy. However, the identified individual predictors may guide physicians to anticipate requirements for neonatal care.

Lifestyle risk factors for cancer: the relationship with psychosocial work environment.

BACKGROUND: Psychosocial work characteristics (job demands, control, support, job strain and iso-strain [high job strain combined with social isolation at work]) may be linked to cancer risk, by affecting cancer-related lifestyles like smoking, high alcohol consumption, low intake of fruits and vegetables and lack of physical activity. METHODS: Cross-sectional data obtained from 3309 respondents participating in an ongoing prospective cohort study in the Netherlands on psychosocial factors and cancer risk were used to study the association between psychosocial job characteristics and lifestyle. Information on job characteristics and risk factor prevalence was collected from 20-65-year-old men and women, through self-administered questionnaires. Multiple logistic and linear regression analyses were undertaken by gender, with adjustment for age and education. RESULTS: No differences in the prevalence of lifestyle risk factors for cancer were found amongst the psychosocial work characteristics studied. Moreover, little evidence was found for a relation between job (or iso-) strain and cancer-related lifestyles in multivariate analyses. CONCLUSIONS: The present study found no support for the hypothesis that job strain or iso-strain are associated with a cancer-related lifestyle. Further research on the role of other psychosocial factors-like personality or social support outside work-in mediating associations between job characteristics and lifestyle, is warranted.

Socioeconomic status and breast cancer incidence: a prospective cohort study.

BACKGROUND: To gain more insight into the relation between socioeconomic status (SES) and breast cancer risk, we have studied that association, before and after adjustment for traditional risk factors for breast cancer, in a prospective cohort study on lifestyle and cancer that started in 1986 in the Netherlands amongst 62,573 women aged 55-69 years. METHODS: At baseline, data on SES, diet, reproductive factors and other covariates were collected by means of a self-administered questionnaire. For data-analysis a case-cohort approach was used. After 3.3 years of follow-up, 471 incident cases were available for analysis. RESULTS: We did not find a higher age-adjusted risk of breast cancer for those with a higher level of education (RR highest/lowest level of education = 0.94, 95% confidence interval [CI]: 0.63-1.39, trend-P = 0.15). Although upper white-collar workers had a slightly higher breast cancer risk than blue-collar workers (RR = 1.16, 95% CI: 0.83-1.62, trend-P = 0.34), women with a profession of higher social standing did not have a higher risk (RR highest/lowest social standing = 0.73, 95% CI: 0.24-2.23, trend-P = 0.86). Additional adjustment for traditional risk factors did not alter the association between SES and breast cancer risk. CONCLUSIONS: We did not find an association between SES and breast cancer risk. This is not in agreement with studies conducted in other European countries and North America.

Lung cancer: is there an association with socioeconomic status in The Netherlands?

STUDY OBJECTIVE: To evaluate if there are differences in lung cancer incidence between socioeconomic groups in the Netherlands and if so, if smoking habits and other lifestyle characteristics could explain these differences. DESIGN: Prospective cohort study. Baseline measurement included information on socioeconomic status, smoking habits, and other covariates by means of a self-administered questionnaire. Follow up was established by computerised record linkage to cancer registries and a pathology register. SETTING: Population originating from 204 municipalities in The Netherlands. PARTICIPANTS: 58,279 men aged 55-69 years in September 1986. After 3.3 years of follow up 490 microscopically confirmed incident lung cancer cases were detected. MAIN RESULTS: An inverse association between lung cancer risk and highest level of education was found, which persisted after adjustment for age, smoking, dietary intake of vitamin C, beta-carotene and retinol (rate ratio (RR) highest/lowest level of education = 0.52, 95% CI 0.33, 0.82, trend p < 0.001). Men with a lower white collar profession had a significantly lower relative rate of lung cancer compared with blue collar workers (RR = 0.66, 95% CI 0.47, 0.96), but after adjustment for smoking habits this difference was reduced (RR = 0.73, 95% CI 0.51, 1.08). CONCLUSIONS: There is an inverse association between highest level of education and lung cancer, which is still apparent after adjustment for age, smoking, dietary intake of vitamin C, beta-carotene and retinol. The significantly lower lung cancer risk of lower white collar workers compared with the risk of blue collar workers could be partially explained by smoking habits.